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Clinical Evaluation of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

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ClinicalTrials.gov Identifier: NCT04059159
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Spinal Singularity

Tracking Information
First Submitted Date  ICMJE August 14, 2019
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date August 16, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Improved bladder management without injury to genito-urinary tract [ Time Frame: 35-40 days ]
    Absence of genito-urinary injury/trauma when using Connected Catheter
  • Successful Bladder Emptying Using Connected Catheter [ Time Frame: 35-40 days ]
    Successful voiding with Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound
  • Freedom from Symptomatic Urinary Tract Infection (UTI) [ Time Frame: 35-40 days ]
    Successful use of the Connected Catheter without significant increase in UTI.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Official Title  ICMJE Clinical Evaluation of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Brief Summary The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Detailed Description Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neurogenic Bladder
  • Urinary Retention
  • Urologic Diseases
Intervention  ICMJE Device: Connected Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Study Arms  ICMJE Experimental: Connected Catheter Users
Intervention: Device: Connected Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males age ≥ 18 with clinical diagnosis of significant urinary retention
  2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy Must have stable urinary management history as determined by the investigator

    OR:

    Must have urodynamic profile suitable for Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)

  3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Connected Catheter, as specified in the Investigational Device Instructions for Use (IFU).

Exclusion Criteria:

  1. Active symptomatic Urinary Tract Infection (UTI), as defined in this protocol (subjects may receive the device after UTI has been treated)
  2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
  3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
  4. Significant intermittent incontinence (between catheterizations)
  5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
  6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)

    1. Urinary tract inflammation or neoplasm
    2. Urinary fistula
    3. Bladder diverticulum (outpouching) > 5cm in size
    4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
    5. Impaired kidney function or renal failure
    6. Active gross hematuria
    7. Active urethritis
    8. Bladder stones
  7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
  8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
  9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
  10. Catheter Assessment Tool screening yields unacceptable results
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Device is currently only designed for use by males.
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bill Colone 949-436-7974 bill@spinalsingularity.com
Contact: Shannon Metzger 949-436-7974
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059159
Other Study ID Numbers  ICMJE ES-NIH-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Spinal Singularity
Study Sponsor  ICMJE Spinal Singularity
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Spinal Singularity
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP